RecallRadar

FDA Device recall Z-1095-2015

Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an ac…

On 2015-02-18 the FDA classified a Class II recall of Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an ac… by Teleflex Medical, citing the packages may contain foreign material (black particles).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1095-2015
ClassificationClass II
Statusterminated
Initiated2015-01-14
Published2015-02-18
Last updated2026-09-13 11:53 UTC
CompanyTeleflex Medical
DistributionUS

Product

Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

Reason

The packages may contain foreign material (black particles).

Identifiers

code_infoProduct Code: 000-40, Lot numbers: BE08, BG05 BG08, BM18, CB11 & CB17.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1095-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.